BEUDAMED
    FDA Recall Terminated

    Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10

    Recall: Z-2024-2021 · Initiated September 9, 2018

    Recall

    Recall Number
    Z-2024-2021
    Event Number
    88165
    Firm
    Vivorte, Inc.
    FEI Number
    3010642815
    Product Code
    MBP
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    September 9, 2018
    Posted
    July 7, 2021
    Terminated
    November 17, 2021
    Address
    1044 E Chestnut St, Louisville, KY, 40204-6033

    Description

    Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10

    Reason

    incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018

    Action

    Vivorte issued Medical Device Removal letter via email on 9/7/2018. Letter states reason for recall, health risk and action to be taken: We recommend that you take the following short-term actions: Ship any Trabexus EB lot MA-170727-01 back to Vivort, Inc. using the included product replacement form. Lot MA-170727-01 will be relabeled to be sent back to you upon request. Contact Therese Montano at [email protected] with further questions

    Distribution

    US state of KY

    Quantity

    12 units